Device, system and method for multiple core biopsy

ABSTRACT

A core biopsy device having a forward-facing cutting edge with either single or dual counter rotating blades is configured to acquire multiple biopsy specimens and temporarily store them within a specimen chamber located beneath the cutting edge. The core biopsy device is insertable and removable from a biopsy channel of an endoscope. The core biopsy device includes an endoscopically visible ruler with depth gauge increments. Other embodiments include deployable depth stops to restrain the plunging of the specimen chamber to not exceed distances preset or selected by the user. Multiple samples contained within the specimen chamber are removed via flushing from a syringe adapter when the device is removed from the endoscope. Alternatively the multiple specimens are removed under applied suction to an external chamber located outside the patient. The order and orientation of the removed specimens are preserved.

CROSS REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of priority to and incorporates byreference in its entirety U.S. Provisional Patent Application Ser. No.61/264,628 filed Nov. 25, 2009.

FIELD OF THE INVENTION

An embodiment of the invention relates generally to biopsy devices usedin endoscopic and other tissue sampling procedures.

BACKGROUND OF THE INVENTION

The traditional biopsy forceps used today typically gather just onebiopsy specimen at a time. The forceps must be removed from the scopeeach time to retrieve the single specimen. This is a tedious and timeconsuming process for standard tissue sampling and even more so forsurveillance biopsies where in excess of 50 specimens may be taken. Alarge variety of endoscopic biopsy forceps are commercially availabletoday with the majority of the market converting to disposable forcepsover the last 15 years. The current design has not fundamentally changedsince its inception over 30 years ago. Whether disposable or reusablethe forceps operate and function in a similar manner. The variety ofbiopsies forceps differ in size of the biopsy cup, the shape of the cup(oval vs. alligator), fenestrated or non-fenestrated (cup with smallopening) and presence or absence of a needle. To operate the traditionaldouble cupped biopsy forceps the cups are closed and advanced throughthe endoscope's instrument channel. Under direct endoscopicvisualization, the forceps are opened and further advanced into aselection of mucosa area for sampling. Pressing the open forceps ontothe mucosa to obtain a specific depth. The forceps are then closed topinch and bite off or tear away forcibly (avulsed) a mucosal sample. Thesample held in the jaw of the forceps is then retrieved by removing thebiopsy forceps from the endoscope. With the aid of an assistant thespecimen sample is removed from the jaws and placed into a vial. Theprocess is then repeated for the subsequent samples. The traditionalbiopsy forceps design creates some of the complications experiencedtoday but is accepted as the standard as there is no better alternativeavailable.

Further detail of the traditional biopsy forceps function and itsshortcomings is as follows: After insertion and the jaws open (spanningtip to tip 7-12 mm), the physician will push the open jaws against themucosal wall with enough pressure he feels is necessary to achieve thedesired depth of sample (with varying degrees of consistency andsuccess). The jaws are then closed to bite and secure that sample andthe forceps are tugged or pulled away to tear away forcibly (avulsed) amucosal tissue sample. However when this is accomplished much of thespecimen is crushed along the outer edges. The quality of a specimensample is judged by the following parameters: weight (mg), size (mm³),depth, crush artifact, sheering effect (artificial distortion of theepithelium) and adequacy of the specimens for histological information.They can be categorized as inadequate, suboptimal, and adequate. As muchas 50% of the specimens are suboptimal or inadequate showing crushartifact or they are superficial so that histopathological assessment isunattainable. As long as more than 50% of the tissue area is not crushedit should allow adequate (not optimal) assessment of thehistopathological features of the specimen. If the depth of the tissuewas less than the full mucosal thickness and/or the mucosal area wasless than 5 mm² then histopathological assessment is compromised.

The traditional biopsy forceps compel gastroenterologist to take biggersamples to compensate for its functional design limitations. This haslead to introduction of larger jawed jumbo forceps spanning tip to tipup to 12 mm. The jumbo forceps' bigger sample provides more for thepathologist to work with. The presumption is the larger samples willallow for proper histological diagnosis with at least a certain numberof the tissue specimens. Unfortunately even with these larger cups agreat percentage is not adequate due to shearing or crush artifact.These inadequate samples have held the key to a more accurate diagnosisbut due to their condition were not salvageable.

As an attempt to streamline the biopsy procedure one manufacture claimsto have a biopsy forceps device that can take up to two tissue specimensin a single pass. The forceps are sold at a premium price as the marketrecognizes the value getting multiple tissue samples in one pass, savingtime. Research indicates this product has not been very successful. Itsdesign actually limits the size of tissue sample and causes additionalcrushing which both reduce the quality for pathology. The conclusion isthat physicians are not willing to give up quality of pathology to savetime.

For decades little has changed with the collection of endoscopic biopsytissue specimens. Once a tissue sample is taken the endoscopic biopsyforceps are withdrawn from the biopsy channel of the endoscope verycarefully by the nurse or GI technician. Colon forceps are 230 cm inlength and upper forceps are 160 cm in length. Both are only 2.3 mm indiameter so much care is taken not to fling patient fluids as they areremoved from the endoscope. Once the forceps are out of the endoscopethe GI assistant maintains control of the distal end and carefully opensthe cups exposing the tissue specimen. At this point the forceps areeither dipped into a specimen vial filled with fixative and shaken todislodge the specimen from the cups of the forceps or the GI assistantuses a needle and carefully picks the tissue out of the open cups andplaces the tissue into the specimen vial. On occasion the GI assistantmay orient the tissue specimen onto a piece of gauze in order to helpfacilitate the laboratory processing. This is a very tedious, timeconsuming process with plenty of opportunity to further damage thespecimen. The forceps are then closed and passed down the biopsy channelto the site where another biopsy is taken and the process is repeatedagain and again until a sufficient number of samples are taken from thisparticular area in question.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred and alternative examples of the present invention aredescribed in detail below with reference to the following drawingsdepicted in FIGS. 1-37:

FIG. 1 schematically depicts a multiple core biopsy device 10 deployablefrom the biopsy channel of a flexible endoscope; having a singlerotating blade affixed to the tissue contact end of a specimen chamber16 to obtain hemispherically cut specimens using a multifunction biopsydevice handle 50;

FIG. 2 schematically depicts a perspective view of the multi-functionbiopsy device handle 50;

FIG. 3 schematically depicts a cross-sectional view of a proximalspecimen chamber 80 connectable with the multi-function handle 50;

FIG. 4 schematically depicts a multiple core biopsy device system 100deployable via the channel of a flexible endoscope;

FIG. 5 schematically depicts a percutaneious multiple core biopsy device200;

FIG. 6 schematically depicts a percutaneious multiple core biopsy system300;

FIG. 7 schematically depicts the operation of the multiple core biopsydevice 10 in a lower intestinal endoscopic procedure;

FIGS. 8A-8F depict movement operations of the multifunction biopsydevice handle 50 to deploy advancement and cutting actions of thespecimen chamber 16;

FIG. 9 depicts side top, and perspective views of the components of themultifunction biopsy device handle to effect the movement actions todeploy and/or implement cutting actions of the specimen chamber 16;

FIG. 10 schematically depicts the deployment of the multiple core biopsydevice 10 from the biopsy channel of a flexible endoscope to obtainmultiple tissue core specimens within anatomical region 2 depicted inFIG. 7;

FIGS. 11A-11C depict deployment of the multiple core biopsy device 10specimen chamber 16 and depth stops 18 from sheath 14;

FIGS. 12A-12D schematically depict the plunging deployment of themultiple core biopsy device specimen chamber 16 to the tissue depthdefined by the depth stops 18 and subsequent cutting action of thesingle edge blade 20 within tissue 19;

FIGS. 13A-13C schematically depict structure and deployment operationsof the perpendicular single blade single axis specimen chamber 116;

FIGS. 14A-14C schematically depict structure and deployment operationsof the angled single blade single axis specimen chamber 120;

FIGS. 15A-15C schematically depict structure and deployment operationsof the perpendicular double blade single axis specimen chamber 124;

FIGS. 16A-16C schematically depict structure and deployment operationsof the perpendicular double blade double axis specimen chamber 128;

FIGS. 17A-17E schematically depict structure and deployment operationsof the angled double blade single axis specimen chamber 132;

FIGS. 18A-18C schematically depict structure and deployment operationsof the angled double blade double axis specimen chamber 136;

FIGS. 19A-19D schematically depict alternative embodiments of depth stopwire configurations deployed from the sheath 14 housing theperpendicular single blade single axis specimen chamber 16;

FIGS. 20A-20B schematically depict structure and deployment operationsof the angled double cantilevered blade single axis specimen chamber140;

FIGS. 21A-21G schematically depict structure and deployment operationsof the perpendicular double cantilevered blade single axis specimenchamber 160;

FIG. 22 schematically depicts structure and deployment operations of theangled single blade single axis specimen chamber 120 with wiredeflection cap 165;

FIGS. 23A-23C schematically depicts alternate configurations of bladecutting surfaces;

FIGS. 24A-24E schematically depicts structure and deployment operationsof a rotary cutting specimen chamber 190;

FIGS. 25A-25F schematically depict structure and deployment operationsof the perpendicular double cantilevered blade single axis specimenchamber 188 with four depth stops 18;

FIG. 26 presents a perspective view of the specimen chamber 16 inrelation to the sheath 14;

FIG. 27 presents an alternate embodiment depiction of the MCB device 10depicted in FIG. 1;

FIG. 28 presents a side view depiction of an alternate embodiment to themultifunction biopsy device handle 50 depicted in FIG. 2;

FIG. 29 presents another depiction of the depth stop 18 deployment fromthe MCB device 10 described in FIG. 11B;

FIG. 30 presents another depiction of the setting of the specimenchamber's 16 plunging distance and advancement to that plunging distancefrom the MCB device 10 described in FIG. 12B;

FIG. 31 presents another depiction of the deployment of the depth stops18 from the MCB 10 described in FIG. 11B;

FIG. 32 presents another depiction of the cutting action by the blade 20from specimen chamber 16 and storage of multiple tissue sections storedwithin the specimen chamber 16 from the MCB device 10 described in FIG.12D;

FIG. 33 presents an alternate cross-sectional and perspective viewsdepicting specimen chamber 188 deployment and blade operation shown inFIGS. 25A-F above;

FIG. 34 presents additional cross-sectional and perspective viewsspecimen chamber 188 deployment and blade operation depicted in FIGS.25A-F above;

FIG. 35 presents another side view and perspective depiction of therigid multi-core specimen biopsy device 200 depicted in FIG. 5 above;

FIG. 36 schematically depicts side and cross-sectional views of anotherdepiction of proximal specimen chamber 80 connectable with themulti-function handle 50 for specimen retrieval via aspiration from thedistal chamber into the proximal chamber with preservation of samplingorder and specimen orientation; and

FIG. 37 schematically depicts side and cross-sectional views ofretrieval of the multiple specimens from the distal chamber via fluidflushing from syringe 355 connected to the biopsy access port 68 into anet 360 with preservation of sampling order and specimen orientation.

DETAILED DESCRIPTION OF THE PARTICULAR EMBODIMENTS

A Multiple Core Biopsy (MCB) device with a substantiallycylindrically-shaped core and a sharp forward-facing cutting edge isconfigured to acquire multiple tissue biopsy samples during a singleendoscopic procedure. The tissue biopsy sections are either temporarilystored within the specimen chamber, or aspirated through the device intoa specimen management system maintaining sampling order and specimenorientation. If they are temporarily stored in the specimen chamber thespecimens are removed by expelling into a specimen management systemafter the MCB is removed for the scope. Expulsion is achieved by areverse fluid flush in communication with the specimen chamber withpreservation of the specimen's order and orientation into a specimenmanagement system. Once the samples are contained in the specimenmanagement system it is removed and labeled for processing. With thespecimen chamber cleared the MCB is ready for alternate site sampling.The MCB device specimen chamber may be configured to have aforward-facing cutting edge fitted with a single pivotable arced cuttingblade rotating about an axis or, alternatively, two counter rotating andopposing arced cutting blades. The sharpness of the forward-facingcutting edge enables acquisition of high quality specimens,substantially free of crush defects.

Other embodiments include a stylet that aids the MCB device to penetratetargeted biopsy sites for single or multiple core specimens taken andretrieved in a similar manner.

Further disclosed are particular embodiments concerning a core biopsydevice having a forward-facing cutting edge with either single or dualcounter rotating blades is configured to acquire multiple biopsyspecimens and temporarily store them within a specimen chamber locatedbeneath the cutting edge. The core biopsy device is insertable andremovable from a biopsy channel of an endoscope. The core biopsy deviceincludes an endoscopically visible ruler with depth gauge increments.Other embodiments include deployable depth stops to restrain theplunging of the specimen chamber to not exceed a set distance. Multiplesamples contained within the specimen chamber are removed via flushingfrom a syringe adapter when the device is removed from the endoscope.Alternatively the multiple specimens are removed under applied suctionto an external specimen management chamber attached to the proximal endof the biopsy access port [without removing the MCB device from thescope]. Either way the order and orientation of the removed specimensare preserved.

Yet further described herein are substantially cylindrically-shapedmultiple core biopsy device having a specimen chamber located within aflexible sheath traversing through the biopsy channel of an endoscope.The specimen chamber is equipped with forward-facing cutting edges andis operable by a multifunction handle manipulated by a user at theproximal end. The multiple core biopsy device includes a distallylocated specimen chamber with forward facing cutting edges intended forplacement in the lumen of an esophagus, internally within the stomach,or internally within the upper and lower gastrointestinal system of apatent. The cutting edges of the specimen chamber are so configured toacquire multiple tissue biopsy samples with preservation of tissueintegrity, orientation, and sequence order acquired in a single-passduring an endoscopic procedure. The configuration of the cutting bladeor blades avoids tissue crushing and provides for clearly delineatedsamples for temporary storage in a specimen chamber during theendoscopic procedure. In other embodiments the shapes of the multiplecore biopsy device may have shapes other than circular. For example, theshapes be include oval, rectangular, square, or triangularconfigurations.

In alternate embodiments the multiple core biopsy device may be fittedwith a specimen management system that utilizes a suction assistedcollection chamber attached to the biopsy access port. Samplestemporally stored in the distally located specimen chamber locatedinternally in-situ within the patient may be removed from the specimenchamber by gentle suction and transferred to the external specimenmanagement system with preservation of tissue sample orientation, andacquisition order. This patient specimen management system provides forcontinued sample collection to resume at different anatomical siteswithout removing the MCB device from the endoscope.

The multiple tissue biopsy sections are stored within the specimenchamber or specimen cavity, or alternatively, aspirated through thedevice and into a specimen management system chamber located at theproximal end of the biopsy device during endoscopic examination andsampling. After biopsy sampling is finished for a specific area inquestion and the specimens are stored within the specimen chamber thebiopsy device is removed from the scope and the specimens are removed byexpelling into a specimen management system with a fluid flush using asyringe in fluid communication with the specimen chamber withpreservation of the specimen's order and orientation.

The core biopsy device may be fitted with either the specimen chamberconfigured to have a forward-facing single pivotable arced cutting bladerotating about an axis or, alternatively, two counter rotating andopposing cutting blades. The multiple specimens obtained from either thesingle rotating blade or the two opposing blades are of high qualitytissue biopsy sections that are substantially free of crush defects.

In general the specification describes below a core biopsy device havinga forward-facing cutting edge with either single or dual counterrotating blades is configured to acquire multiple biopsy specimens andtemporarily store them within a specimen chamber located beneath thecutting edge. The core biopsy device is insertable and removable from abiopsy channel of an endoscope. The core biopsy device includes anendoscopically visible ruler with depth gauge increments. Otherembodiments include deployable depth stops. A user plunges the biopsydevice to a selected tissue depth, by selecting variable rulerincrements. Biopsied tissue is then excised in sizes defined by thetravel path of the single blade or dual cutting blades and plungeddistances, and contained within the specimen chamber. Multiple samplescontained within a specimen chamber are removed via flushing from asyringe adapter when the device is removed from the patient. The orderand orientation of the removed specimens are preserved.

The core biopsy device described herein is configured to acquire atleast one tissue biopsy sample within a tubular-shaped cavity orspecimen chamber. The core biopsy device is insertable and removablefrom a biopsy channel of an endoscope and includes a single rotatingcutting blade or dual counter rotating cutting blades at the tissuecontact end of a tube having a cavity. The core biopsy device includesan endoscopically visible ruler with depth gauge increments and includedeployable depth stops. A user plunges the biopsy devices to a selectedtissue depth. Biopsied tissue is then excised in sizes defined by thetravel path of the single blade or dual cutting blades and plungeddistances, and contained within a specimen chamber. Samples containedwithin a specimen chamber during a single endoscopic procedure areremovable via flushing from a syringe adapter such that the biopsiedtissue specimens are flushed from the forward facing cutting edgeskeeping the specimens in order and orientation.

Also described below includes a core biopsy device configured to acquireat least one tissue biopsy sample within a tubular cavity is described.The core biopsy device is insertable and removable from a biopsy channelof an endoscope and includes an outer protective sheath a singlerotating cutting blade or dual counter rotating cutting blades at thetissue contact end of the inner core tube having a cavity. The corebiopsy device include an endoscopically visible ruler with depth gaugeincrements. Other embodiments include deployable depth stops. A userplunges the biopsy devices to a selected tissue depth. Biopsied tissueis then excised in sizes defined by the travel path of the single bladeor dual cutting blades and plunged distances, and propelled into thetube cavity as a consequence of applied cutting, tissue plunging forcesand potentially controlled aspiration. Biopsy procedures are repeated asdesired and sequential and multiple tissue sections are propelled intothe cavity to displace the previous biopsy section deeper into thetubular cavity. Other descriptions include a multiple core biopsy systemutilizes a flushing syringe to expel and remove multiple biopsy sectionsin reverse order to their endoscopic sampling while at the same timemaintaining order and orientation.

The multiple core biopsy device is insertable and removable through thebiopsy channel of an endoscope. Particular embodiments of the corebiopsy device includes a single rotating cutting blade or dual counterrotating cutting blades at the tissue contact end of tubular chamberthat houses the biopsy specimens during an endoscopic procedure. Thecore biopsy device includes an endoscopically visible ruler with depthgauge increments that is on the exterior side of the specimen chamber.Other embodiments include deployable tissue plunger stops. A userplunges the biopsy devices to a selected tissue depth. Biopsied tissueis then excised in sizes defined by the travel path of the single bladeor dual cutting blades and plunged distances, and propelled into thetube cavity as a consequence of applied cutting and tissue plungingforces. Biopsy procedures are repeated as desired and sequential andmultiple tissue sections are propelled into the cavity to displace theprevious biopsy section deeper into the tubular cavity. Otherdescriptions include a multiple core biopsy system utilizes a flushingsyringe to expel and remove multiple biopsy sections in reverse order totheir endoscopic sampling while at the same time maintaining order andorientation. Another embodiment of the core biopsy device appliescontrolled suction to the proximal end of the device aspirating theindividual tissue specimens into the Specimen Management System in orderto their endoscopic sampling while at the same time maintaining orderand orientation of subsequent samples.

Illustrated below are embodiments for a single cutting blade andmultiple cutting blade biopsy devices and describe systems and methodsof procuring multiple biopsy tissue samples from a single endoscopicexamination substantially devoid of crush artifacts. In general a corebiopsy device operable by a user is described. In one embodiment, thecore biopsy device includes a flexible tube having a tissue contact end(distal), a manipulation end controllable by the user (proximal), and acavity located between the tissue contact and manipulation ends. At thetissue contact end resides a rotatable cutting blade. Connected betweenthe rotatable cutting blade and the manipulation end is a blade controlmember. Biopsy tissue is obtained during endoscopic procedures when theuser plunges the tissue contact end to a set depth, manipulates theblade control member from the manipulation end to pivot the rotatablecutting blade to excise a tissue section defined by the travel path ofthe rotatable cutting blade, and insert the tissue section into thecavity as a consequence of the cutting and plunging forces applied tothe excised tissue. Other embodiments allow for the rotatable cuttingblade to comprise two counter-rotating sections. Multiple biopsy samplesmay be acquired by repeating the plunging and cutting action by eitherthe single rotating cutting blade or dual counter-rotating cuttingblades wherein a sequential excised tissue sections are propelled intothe cavity, thereby displacing the earlier sampled tissue sectionfurther into the cavity. A series of sequential biopsies may be thusacquired with minimum crush effect during a single pass of the biopsydevice.

In another embodiment, a multiple core biopsy (MCB) system is described.The multiple core biopsy system includes the biopsy device having aflushing port located near the manipulation end. The flushing portdetachably receives a syringe having a flushing fluid. For sequentialbiopsies located in the cavity, either obtained by the single rotatingcutting blade or the dual counter-rotating cutting blades biopsydevices, the multiple core biopsy device is removed from the endoscope,and receives a fluid flush delivered from the (proximal) manipulationend. The fluid flush thereby displaces the tissue section biopsies inreverse order to the order that they were sampled during the single passof the biopsy device.

In yet other embodiments described include a biopsy device having aremovable stylet, the biopsy device being operable by a person who isusing an image-guided system. The biopsy device includes a rigid sheathequipped with the removable stylet, the rigid sheath having depthmarkings visible by the image-guided system and a terminus with a distalchamber configured with a forward facing cutting edge comprising a fixedblade and at least one movable blade. The biopsy device further includesa manipulation end controllable by the user to plunge the forward facingcutting edge at a sampling locus after removal of the stylet at a depthselected by the user based on the depth markings and to engage a cuttingaction by the at least one movable blade at the depth selected toacquire at least one specimen storable in the distal chamber. The biopsydevice may acquire additional depths obtained at deeper depths at thesampling locus. The rigid sheathed biopsy device may also be transferredto a different sampling locus to acquire additional specimens procuredat increasing depths at that different sampling locus.

Other embodiments of the multiple core sampling device provide for aflexible sheath having a distally located specimen chamber that isfitted with forward facing cutting surfaces, having a fixed and moveableportion that when the moveable portion is in the stowed position, isthen configured for tissue plunging at controlled distances. To insurethat unwanted tissue is not sampled while undergoing sheath insertionfor placement at an anatomical region-of-interest for sought-aftertissue sampling, the flexible sheath is also fitted with a stylet toprevent the unwanted entrance of tissues not desired for specimensampling. Once the distal specimen chamber is positioned for multiplecore biopsy sampling at the anatomical region-of-interest, the stylet isremoved to allow specimen retrieval into the distal specimen chamberfrom multiple plunge-and-cut operations at pre-set or user-adjustedspecimen chamber plunging depths. The cut operations occur after theplunging action to the pre-set or user-selected depths by the deploymentof the moveable from its stowed position.

Particular embodiments of the biopsy devices, systems, and methodsencompass obtaining mucosal biopsies of the esophagus, stomach, smallintestine, and large intestine. Endoscopic guided biopsies are theprimary diagnostic approach to most GI disorders. Biopsy specimensobtained at endoscopy help not only to differentiate benign frommalignant diseases, but also to establish the precise nature of theabnormality, be it infectious, inflammatory, or neoplastic.

FIGS. 1-37 illustrate systems and devices for a MCB (multiple corebiopsy) device that provides superior design and functionality to thatof traditional biopsy forceps which rely on bigger specimens for qualitysamples. The MCB design provides for multiple specimens in a singlepass, which speeds the procedure and reduces patient sedation time. Dueto the cutting blade embodiment designs described, the MCB devicevirtually eliminates the crush factor inherent in the traditional biopsyforceps design. In all, a higher number of superior quality, consistentdepth biopsy specimens are procured from the suspect area in the sametime it takes to obtain a single traditional biopsy specimen. Generallyan increased number of biopsy specimens correlates to a higher detectionrate with improved outcomes.

The MCB device, which provides an advanced design and functionality,would soon expect to become the standard for taking diagnostic biopsies.This meshes well in a managed-care environment where everyone is beingpressured to do more with less facilitating faster procedural turnaroundtime with improved outcomes.

Further clinical advantages of the MCB include that specimens may betaken and kept in order and orientated, and have consistent depth viadepth stops, set core advancement and blade swing as discussed belowthat provides or precise variable depth sampling. The MCB includes aninternal reservoir channel allows for easy retrieval and transferring ofmultiple specimens and a single or dual-motion cutting mechanismsmoothly severs the specimen at the prescribed depth virtuallyeliminating any crush artifact so that specimens may be obtained withminimal mucosa surface area disruption providing less bleeding. The MCBdesigns, as discussed below, provide for rapid target specimen selectionaids in speeding of obtaining biopsy specimens in a single MCBinsertion. The MCB includes a forward facing cylindrical cutting edgehaving a single arced cutting blade or dual opposing cutting blades.Aspiration may be controlled by a MCB user during tissue biopsies eitherright after the specimen is excised or right prior to or as thephysician or other user is thrusting the device into the mucosal wallfor a subsequent sample. Removal of the specimens from the MCB isaccomplished by either removing the MCB from the scope and flushingspecimens retrograde out the distal end or by aspiration through theentire length of MCB device into a specimen management system outsidethe body while the MCB device remains in the scope and patient. Thespecimen retrieval methods maintain or preserve the orientation andorder of the tissue specimens.

FIG. 1 schematically depicts a multiple core biopsy device 10 (MCB 10)deployable from the biopsy channel of a flexible endoscope. The MCB 10includes a single rotating blade 20 affixed to the tissue contact end ofa specimen chamber 16 to obtain hemispherically cut specimens using amultifunction biopsy device handle 50. The specimen chamber 16 isaccessed from the multifunction biopsy device handle 50 of the MCB 10via the biopsy access port 68 through the specimen channel which routesthrough to the distal tip. The specimen channel is a coaxial lumen thatmoves within the exterior cannula or sheath 14, that is flexible andengageable with the biopsy channel of an endoscope. The luer-lock allowsa syringe (not shown) to be connected with biopsy access port 68 toflush multiple core specimens from the specimen chamber 16 after thecannula 14 is removed from the endoscope. Alternatively, the biopsyaccess port 68 may be connected to a proximal specimen management systemdescribed in FIGS. 3 and 4 below. The specimen chamber 16 includesmultiple markings 17, each marking denoting a standard length. The sizeof the tissue cut is defined by the plunge distance and thehemispherical traveling distance defined by the single rotatable blade20. Deployment of depth stops 18 limit the plunge depth of the forwardfacing cutting edge of the specimen chamber 16.

The cannula or sheath 14 is passed through the biopsy channel of aflexible endoscope as shown in FIG. 7 below. Operation of themultifunction handle 50 to engage the depth stops 18, advance thespecimen chamber 16 and to activate cutting action by the blade 20 isdescribed in FIGS. 8A-F below. Other specimen chambers, includingchambers 116, 120, 124, 128, 132, 136, 140, 160, 188 and 190 shown anddescribed in FIGS. 8A-25D discussed and shown below, may be similarlyfitted to the biopsy device 10. Additional structural features of thespecimen chamber 16 in relation to the sheath 14 is illustrated anddescribed in FIG. 26 below.

Cross-section along line A-A shows depth stop control wires 35, and abladeblade control wire 37. The wires convey mechanical motion betweenthe respective depth stops 18, and cutting blade 20 at the distal end,and with multifunction handle 50 controls 54 and 56 discussed in FIG. 2below.

FIG. 2 schematically depicts a perspective view of the multi-functionbiopsy device handle 50. The handle 50 includes a depth stop deploymentcontrol 54, a specimen chamber advancement control 61, and a bladeactivation control 66. The exemplary configuration shows that depth stopdeployment control 54 having back-and-forth slidable motion along thelong axis of the handle 50, the specimen chamber advancement control 61having clockwise and counterclockwise rotary motion perpendicular to thelong axis, and the blade activation control 66 having back-and-forthslidable motion along the long axis. Other motion configurations of thecontrols 54, 61, and 66 are possible. The back-and-forth androtation/counter rotation motions provide the push and pull motionsconveyed to stow or deploy the specimen chamber 16, the depth stops 18,and the rotary cutting action of the blade 20. The blade activationcontrol 66 includes a motion limiter 58 that limits rotary cuttingaction to not exceed beyond that rotary motion needed to convey acomplete cut of the blade 20 and a thumbhole 66 to ergonomically andconveniently be manipulated by the user or handle 50 operator.

FIG. 3 schematically depicts a cross-sectional view of a proximalspecimen management system 80 connectable with the multi-function biopsydevice handle 50 via biopsy access port 68. Internal specimen managementchamber 84 is connectable with the biopsy access port 68 and uponreceiving suction conveyed via suction channel 86, single or multiplesamples temporarily housed in the distally located specimen chamber 16located internal within the patient are transferred to the specimenmanagement chamber 84. Transferred single or multiply acquired specimensare structurally preserved and in the order and orientation of thespecimens taken.

FIG. 4 schematically depicts a multiplecore biopsy system 100 (MCBS 100)deployable via the biopsy channel of a flexible endoscope shown in FIGS.7 and 10 below. A suction source V is connectable with the suctionchannel 86. Upon application of a suction, either as applied by asyringe (not shown), suction pump (not shown) or house suction source(not shown), any specimens temporarily housed within the specimenchamber 16 are transferred to the specimen management chamber 84 withmaintenance of specimen integrity and sampling order and orientation.Other specimen chambers, including 116, 120, 124, 128, 132, 136, 140,160, 188 and 190 (not shown) described in FIGS. 8A-25D discussed andshown below, may be similarly configured with the MCBS 100.

FIG. 5 schematically depicts a percutaneous multiple core biopsy (PMCB)device 200. Used in conjunction with image-guided systems (not shown)such as ultrasound or X-ray visualization technologies, the PMCB 200includes the proximally located multifunctional handle 50 connected witha semi-rigid to rigid shaft 214 to which may be fitted at its distal endthe specimen chambers 16. Other specimen chambers, including 116, 120,124, 128, 132, 136, 140, 160, 188 and 190 (not shown) described in FIGS.8A-25D discussed and shown below, may be similarly fitted to the PMCBdevice 200. Multiple specimen cores may be consecutively obtained withinthe same puncture locus of a targeted organ, say a lung, kidney orliver, to obtain structurally preserved, devoid of crush artifacts, andmaintenance of specimen integrity and sampling order and orientation toallow meaningful histological examination. Incremental markings 17,having a known distance between each marking 17 of 1 or 2 mm, may bemade with radio-opaque markings to be visible in X-ray guidance systemsor other contrast agent media to make visible in ultrasound guidancesystems.

Cross-section along line B-B shows the blade wire 37 which conveysmechanical motion between the blade 20 of specimen chamber 16 at thedistal end and with multifunction handle 50 blade control 56 discussedin FIG. 2 above. The handle 50 operator plunges the PMCB device 200using the markings distance 17. The operator engages blade control 56 toacquire a blade 20 cut histological quality specimen and plunges deeperwithin the same organ puncture locus to acquire additional specimenssimilarly cut by the blade 20 via blade control 56.

FIG. 6 schematically depicts a percutaneous multi-core biopsy system300. Connectable with the proximal specimen chamber 80 that isattachable to a suction source V, multiple samples obtained at aparticular organ puncture location may be transferred under suction tothe proximal specimen management chamber 80 once removed the PMCB deviceis removed from the organ or patient. Under image guidance systems (notshown) or direct vision, the specimen chambers 16, or alternatively,specimen chambers 116, 120, 124, 128, 132, 136, 140, 160, 188 and 190described in FIGS. 8A-25D below may proceed to another organ puncturelocus to obtain a different set of multiple specimens for temporarystorage within specimen chambers 16-190. Once removed from the patient,a gentle source of suction V, say via a syringe, pump, or room providedsuction may be applied to transfer the different set of multiplespecimens from distally specimen chambers 16-190 to proximally locatedspecimen management chamber 80.

FIG. 7 schematically depicts the operation of the multiple core biopsydevice 10 in a large intestinal endoscopic procedure conducted by anoperator. Endoscope 40 receives the sheath 14 of MCB 10 or MCBS 100through endoscope 40 biopsy port 42 and is passed through the biopsychannel located within endoscope 40 insertion tube 45. By way ofexample, insertion tube 45 is routed through the large gastrointestinaltrack's ascending, transverse, and descending branches. Respectivecutaways show a first anatomical region AR1, a second anatomical regionAR2, and a third anatomical region AR3. The specimen chamber 16 isdeployed from the endoscope's 40 biopsy channel to obtain consecutivetissue core specimens within anatomical regions 1, 2, or 3. As depictedthe MCB device 10 or the MCBS 100 may be used for ocular-basedendoscopes as shown, or alternatively, for video-based endoscopes (notshown) in which images of the MCB device 10 operation is presented onnearby monitors (not shown) viewable by the MCB device 10 or MCBS 100user.

FIGS. 8A-8F depict movement operations of the multifunction biopsydevice handle 50 to deploy depth stops, advance the specimen chambercore 16, and activate the cutting blade 20. The general method of usingthe MCB 10 or MCBS 100 begins with the specimen chamber 16 is retractedwithin the sheath 14 and blade 20 in a stowed or un-deployed state toallow the MCB/S 10/100 to be safely passed through the biopsy channel ofthe endoscope depicted in FIG. 7. Once it exits the distal end of theendoscope in direct visualization of the physician the depth stops 18are deployed (Step 1). As shown in FIGS. 8A/8B, the depth stopdeployment control 54 is slid in the direction of the motion arrow alongchannel 60. After deployment of the depth stops 18 performed in Step 1,the core biopsy specimen chamber or shaft 16 can be advanced to the setdepth, and so emerges beyond the terminus of the sheath 14 (Step 2) tobe equivalent to the plunging depth defined by the consistent depth viadepth stops 18, set core advancement and blade swing. As shown in FIG.8C, rotation of the specimen chamber control 61 will advance thespecimen chamber 16 to a set depth. Once the specimen chamber isadvanced, a biopsy location is chosen for receiving the plunging orthrusting action of the specimen chamber 16 into the mucosal wall to theset depths in which the depth stops 18 prevent the specimen chamber 16from further penetration than desired. Once the specimen chamber 16 isplunged to the set depth the blade control member 66 is advanced (Step3) and the tissue specimen excised by cutting action of the blade 20.The thumbhole 66 provides an ergonomic structure to exert pushing orpulling actions of the blade control. The MCB 10 or MCBS 100 isretracted from the mucosal wall, and the blade control 66 is engaged tostow the blade 20 back into its un-deployed state and another biopsysite is selected and Step 3 is repeated until the desired numbers ofbiopsies are retrieved. Previously collected specimens already occupyingthe lumen space of the specimen chamber 16 are further displaced moreinternally therein, as shown in FIGS. 25D-F below. At this point thespecimen chamber shaft control 61 is turned to retract the specimenchamber 16 into sheath 14. The depth stop control 54 is then pulled backto retract the depth stops 18 within the sheath 14. If specimenstemporarily housed within the lumen space of the specimen chamber 16 arenot suction transferred to the proximal specimen management chamber 80shown in FIG. 4, the sheath 14 is removed from the biopsy channel of theendoscope to allow removal via retrograde flushing of the specimenscontained within the lumen of the specimen chamber 16 with preservationof sample integrity and sampling order and orientation.

FIG. 9 depicts side top, and perspective views of the components of themultifunction biopsy device handle to effect the movement actions todeploy and/or implement cutting actions of the specimen chamber 16.Depth stop deployment is conveyed by the depth stop slider control 54that is mechanically connectable with the depth stop wire 35. Deploymentof the depth stops 18 is initiated by downward direction of the slidercontrol 54 until locked into place, and retraction or stowage of thedepth stops 18 is initiated by movement reversal, that is, upwardmovement conveyed by the slider control 54 to the depth stop wire 35.The slider control 54 has a projection 53 engagement with slot 55 ofspecimen chamber control 61. The depth stops 18 are deployed first. Theremoval of the projection 53 from the slot 55 allows rotary operation ofthe specimen chamber control 61 to permit deployment of the specimenchamber 16 beyond the distal terminal end of the sheath 14.

The rotary motion of the specimen chamber control 61 is conveyed byhelical turns 94 that engages motion converter 93. Specimen chamber wire33 is attached to crossbar 97 that engages motion converter's 93 curvedslot 95 to produce a linearly directed, back-and-forth or push-pullmotion along the long axis of handle 50 to and through the specimenchamber wire 33 which advances and retracts the specimen channel whichincludes the specimen chamber.

The back-and-forth or push-pull motion by the thumbhole 66 is conveyedby slotted shaft 56 that is mechanically coupled with the blade wire 37.Cutting action by the blade 20 is conveyed by a downwardly directedpushing force applied to the thumbhole 66 by a handle 50 user oroperator. Similarly, retraction of the blade 20 to its stowed positionis initiated by an upwardly directed pulling force conveyed by thethumbhole 66. Conversely, the handle 50 can be configured such that anupward pulling motion engages cutting action and a downward pushingmotion engages blade stowage.

After specimens are collected within the specimen chamber 16, the blade20 is returned to its stowed state by motion of thumbhole slider 66.Thereafter, the specimen chamber control 61 is rotated to retract thespecimen chamber 16-190 to place the slot 55 to be engageable with theprojection 53. Upward movement of the depth stop slider control 54retracts depth stops 18 within the sheath 14 upon slidable engagement ofthe projection 53 with slot 55.

FIG. 10 schematically depicts tissue specimen sampling deployments ofthe multiple core biopsy device 10 from the biopsy channel of a flexibleendoscope to obtain multiple tissue core specimens within anatomicalregion 2 depicted in FIG. 7. Here three separate deployments of thespecimen chamber 16 with the depth stops 18 set, one deployment depictedwith solid lines and two deployments depicted in dashed lines. Operationof the blade 20 after the specimen chamber 16 has been plunged into thetissue to obtain histological grade core specimens depicted in FIGS.12A-D below.

FIGS. 11A-11C depicts deployment of the multi-core biopsy device 10specimen chamber 16 and depth stops 18 from sheath 14. Prior to plungingthe forward facing cutting surfaces of the specimen chamber's 16 movableblade 20 and/or stationary regions, the specimen chamber is advancedfrom its sheath 14 and locked into place via specimen chamber control 61of multifunction handle 50. In FIG. 11A the depth stops 18 are fullyretracted or in a stowed position. In FIG. 11B, the depth stops 18emerge from the sheath 14 while the specimen chamber 16 remainsretracted within the sheath 14. In FIG. 11C, the specimen chamber 16 isadvanced externally from the lumen of the sheath 14 via the handle's 50specimen chamber control 61. The specimen chamber 16 is set for plunginginto the mucosal wall depicted in FIG. 12A-D below within a particularanatomical region, say AR1, 2, or 3 depicted in FIGS. 7 and 10 above.

FIGS. 12A-12D schematically depict the plunging deployment of themultiple core biopsy device specimen chamber 16 to the tissue depthdefined by the depth stops 18 and subsequent cutting action of thesingle edge blade 20 within tissue 19. These cross-sectional depictionsof FIG. 12A show the operation of specimen chamber 16 during multiplecore biopsy sampling as would be undertaken within anatomical region 2of FIG. 10 above. In general the multifunction handle 50 of the MCB 10or MCBS 100 has the deployable depth stops 18 set by operatormanipulation of the handle's 50 depth stop control 54 shown in FIG. 2.

In FIG. 12B the specimen chamber or biopsy core 16 is advanced bymanipulation of the handle's 50 specimen chamber control 61 andsubsequently pressed, thrusted, or plunged into the tissue. Cuttingcommences after plunging by manipulation of the handle's 50 bladeactivation control 56.

In FIG. 12C cutting action is completed by continued manipulation of thehandle's 50 blade activation control 56. A newly cut specimen is therebyacquired.

Thereafter, in FIG. 12D, the newly cut specimen is delivered and pushedinto temporary storage within the lumen of the specimen chamber orbiopsy core 16 by re-plunging the advanced specimen chamber or biopsycore 16 into the tissue, thereby displacing or pushing the previousnewly acquired cut further internally within the lumen space of thespecimen chamber 16.

FIGS. 13A-13C schematically depict structure and deployment operationsof the perpendicular single blade single axis specimen chamber 116.Presented in FIG. 13A are two cutting edges, the edge of the moveableblade 20 and the edge of the fixed portion of the facing edge of thespecimen chamber 116. In the stowed position, both the cutting edge ofthe blade 20 and the cutting edge of the fixed portion is perpendicularto the long axis of the specimen chamber 116. The blade is rotatableabout single axis pivot 22. Depth stops 18 are deployed through sheathapertures 121 via deflector posts 123.

In FIG. 13B, the specimen chamber is shown deployed. The arc of theblade 20 is deployed midway via blade control wire 37 and is at maximumheight by almost the length of the blade 20. In FIG. 13C, the specimenchamber is shown deployed and the cutting action complete with the blade20 pushed to maximum movement via blade control wire 37 and resting onthe fixed portion end 21 in FIG. 13B.

FIGS. 14A-14C schematically depict structure and deployment operationsof the angled single blade single axis specimen chamber 120. Presentedin FIG. 14A are two cutting edges, the edge of the moveable blade 122and the edge of the fixed portion 125 of the facing edge of the specimenchamber 120. In the stowed position, both the cutting edge of the blade122 and the cutting edge of the fixed portion 125 is angled or beveledrelative to the long axis of the specimen chamber 120. The blade 122 isrotatable about single axis pivot 22. Depth stops 18 are similarlydeployed through sheath apertures 121 via deflector posts 123.

In FIG. 14B, the specimen chamber 120 is shown deployed from theterminus of the sheath 14. The arc of the blade 122 is deployed midwayvia blade control wire 37 and is at maximum height by almost the lengthof the blade 122. In FIG. 14C, the specimen chamber 120 is showndeployed and the cutting action completed with the blade 122 pushed tomaximum movement via blade control wire 37 and resting on the fixedportion end 125.

FIGS. 15A-15C schematically depict structure and deployment operationsof the perpendicular double blade single axis specimen chamber 124.Presented in FIG. 14A are two rotatable cutting edges pivotable aboutsingle axis 22, a smaller cutting blade 126 and a larger cutting blade128. The edge of the moveable blades 126 and 128 are the forward facingcutting surfaces of the specimen chamber 124. In the stowed position,both rotatable cutting edges of the knives 126 and 128 are perpendicularrelative to the long axis of the specimen chamber 124. The knives 126and 128 are rotatable about single axis pivot 22. Depth stops 18 aresimilarly deployed through sheath apertures 121 via deflector posts 123.

In FIG. 15B, the specimen chamber 124 is shown deployed from theterminus of the sheath 14. The arcs of the larger blade 128 and smallerblade 126 are approaching midway deployment via blade control wire 37.

In FIG. 15C, the specimen chamber 124 is shown deployed and the cuttingaction completed with the larger blade 128 overlapping the smaller blade126.

FIGS. 16A-16C schematically depict structure and deployment operationsof the perpendicular double blade double axis specimen chamber 128.Presented in FIG. 16A are two rotatable cutting edges or blades 132pivotable about their own axis 134. Each blade 132 counter-rotatesrelative to the other. The edge of the moveable blades 132 are theforward facing cutting surfaces of the specimen chamber 128. In thestowed position, both rotatable cutting edges 132 are perpendicularrelative to the long axis of the specimen chamber 128. The blades 132are rotatable about their own axis pivot 134. Depth stops 18 aresimilarly deployed through sheath apertures 121 via deflector posts 123.

In FIG. 16B, the specimen chamber 128 is shown deployed to the terminusof the sheath 14. The arcs of the blades 132 are approaching midwaydeployment via blade control wires 37.

In FIG. 16C, the specimen chamber 128 is shown deployed and the cuttingaction completed with the knives 132 abutting against each other tocomplete specimen severing.

FIGS. 17A-17E schematically depict structure and deployment operationsof the angled double blade single axis specimen chamber 132. Presentedin FIG. 17A are two counter rotatable cutting edges or blades, a smallerblade 134 and a larger blade 138, each counter rotatable to the othervia pivot or axis 22. The larger blade 138 counter-rotates relative tothe smaller blade 134 until cutting action is completed when largerblade 138 overlaps smaller blade 134. The edge of the moveable blades134 and 138 are the forward facing cutting surfaces of the specimenchamber 132. In the stowed position, both counter rotatable cuttingedges 134 and 138 are angled or beveled relative to the long axis of thespecimen chamber 132. The blades 134 and 138 are rotatable about thecommon pivot 22 they share. Depth stops 18 are similarly deployedthrough sheath apertures 121 via deflector posts 123.

In FIGS. 17B and 17E, the specimen chamber 132 is shown deployed fromthe terminus of the sheath 14. The arcs of the blades 134 and 138 areapproaching midway deployment via blade control wires 37.

In FIG. 17C, the specimen chamber 128 is shown deployed and the cuttingaction completed with the larger blade 138 overlapping the smaller blade134 to complete specimen severing.

FIGS. 17D-E depicts in perspective view the advancement of the specimenchamber 132 advanced from the terminus of the sheath 14. In FIG. 17D theblades 134 and 138 are stowed, have an angled configuration relative tothe long axis of chamber 132, and ready for plunging into an anatomicalregion. In FIG. 17E the small and larger blades 134 and 138 are midwaydeployed during cutting action. More easily seen are the common pivots22 to which small and large blades 134 and 138 rotate and the sheathapertures 121 from which the depth stops 18 emerge.

FIGS. 18A-18C schematically depicts structure and deployment operationsof the angled double blade double axis specimen chamber 136. Presentedin FIG. 18A are two counter rotatable cutting edges or blades 138 ofsubstantially equal length in a stowed state that provide the forwardfacing cutting edges in an angled or beveled configuration relative tothe long axis of the specimen chamber 136. Depth stops 18 are similarlydeployed through sheath apertures 121 via deflector posts 123.

In FIG. 18B, the specimen chamber 136 is shown deployed from theterminus of the sheath 14. The blades 138 are rotatable about their ownaxis pivot 134. The arcs of the blades 138 are approaching midwaydeployment via blade control wires 37. One blade 138, being higher thanthe other blade 138, provides the larger cutting arcIn FIG. 18C, thespecimen chamber 136 is shown deployed and the cutting action completedwith the higher positioned blade 138 abutting against the lowerpositioned blade 138 to complete specimen severing.

FIGS. 19A-19D schematically depict in perspective and top viewsalternative embodiments of depth stops 18 configurations deployed fromthe sheath 14 housing the perpendicular single blade 20 single axisspecimen chamber 16. Perspective views show a partially deployed blade20 and that specimen chamber 16 is shown advanced beyond the terminalend of the sheath 14. Top views do not illustrate partially deployedblade 20 but do illustrate positioning of deployed depth stops 18/118 inrelation to sheath 14 and specimen chamber 16. The alternateconfigurations provide for more contact points to secure levels offooting to deploy plunging operations of the advanced specimen chamber16.

FIG. 19A illustrates two deployed depth stops 18, one clearly seen toemerge from sheath aperture 121. The depth stops 18 are diagonallypositioned relative to each other, that is, about 120 degrees apart fromthe center of the chamber lumen 125 and provide for a two-legged standfrom which to engage plunging of the deployed specimen chamber 16.

FIG. 19B illustrates three deployed depth stops 18, two clearly seen toemerge from sheath apertures 121. The depth stops 18 are about 120degrees apart from each other relative to the center of the chamberlumen 125 and provide a tripod-like stability from which to engageplunging of the deployed specimen chamber 16.

FIG. 19C illustrates four deployed depth stops 18, two clearly seen toemerge from sheath apertures 121. The depth stops 18 are about 90degrees apart from each other relative to the center of the chamberlumen 125 and provide for a four-legged stand from which to engageplunging of the deployed specimen chamber 16.

FIG. 19D illustrates two deployed depth stop loops 118, the loopsdeployed from the sheath apertures 121. The stop loops 118 are deployedacross from each other and provide for additional stability from whichto engage plunging of the deployed specimen chamber 16.

FIGS. 20A-20B schematically depicts structure and deployment operationsof the angled double cantilevered blade single axis specimen chamber140.

FIG. 20A presents the cantilevered specimen chamber 140 configured withtwo cutting blades in an angled configuration, a small cutting blade 142with a lever projection 144, and a larger cutting blade 146 with a leverprojection 148. Each blade 142/146 rotates about pivot axis 150 sharedbetween them. Blade control wires 37 connects to lever projections 144and 148. Depth stops 18 are shown deployed.

FIG. 20B presents deployment of small blade 142 and large blade 146 ofthe cantilevered specimen chamber 140. A downward pulling actionconveyed by the blade control wires 37 initiated by the downward actionapplied by the operator to thumbhole 66 of multifunction handle 50 shownin FIG. 2 engages rotation of small blade 142 and large blade 146, eachcounter-rotating relative to the other to commence cutting action. Theblades 142/146 are returned to the stowed position by a pulling actionapplied to the thumbhole 66 by the user operating the handle 50.

FIGS. 21A-21G schematically depicts structure and deployment operationsof the perpendicular double cantilevered blade single axis specimenchamber 160.

FIG. 21A presents the cantilevered specimen chamber 160 configured withtwo cutting blades in a perpendicular configuration, a small cuttingblade 162 with a lever projection 164, and a larger cutting blade 166with a lever projection 168. Each blade 162/166 rotates about pivot axis150 shared between them. Blade control wires 37 connects to leverprojections 164 and 168. Depth stops 18 are shown deployed.

FIGS. 21B-D schematically depicts perspective views of cutting action,retraction, and stowage of the blades 162/166. Presented in FIG. 21B, adownward applied pulling action applied by the operator to thumbhole 66of multifunction handle 50 shown in FIG. 2 engages rotation of theblades 162/166 to their completed, cutting state, with the smaller blade162 enveloped within the larger blade 166. When a pulling force isapplied to the thumbhole 66 of handle 50 as shown in FIGS. 21C and D,the blade control wires move upward to retract the blades 162/166 to thestowed state.

FIGS. 21E-G schematically depicts side views of specimen sampleprocurement from completion of cutting action, retraction, and stowageof the blades 162/166. Depth stops 18 are deployed. Specimens ofhistological quality 170 are housed within the lumen of specimen chamber160. Presented in FIG. 21E a downward applied pulling action applied bythe operator to thumbhole 66 of multifunction handle 50 shown in FIG. 2engages rotation of the blades 162/166 to their completed, cutting stateto severe a histological grade specimen devoid of crush artifacts. Asshown in FIGS. 21F and G, when a pushing force is applied to thethumbhole 66 of handle 50 the blade control wires 37 move upward toretract the blades 162/166 to the stowed state.

FIG. 22 schematically depict structure and deployment operations of theangled single blade single axis specimen chamber 120 with depth stopdeflection cap 165. Depth stop deflection cap 165 may be inserted intothe sheath 14 such that deflectors 123 are aligned with sheath apertures121.

FIGS. 23A-23C schematically depicts alternate configurations of bladecutting surfaces. FIG. 23A shows a single edge razor configurationfacing internally (per left inset) and curved with the semi-circularblade 20 pivoting about the forward face of specimen chamber 16. Inother embodiments, as shown in the middle inset of FIG. 23A, the singleedge razor may face outward, that is the razor sharp edge may be occupythe largest external arc of the blade 20, external such that the razor'sedge is at the maximum arc. Or, alternatively, the razor may be doubleedge shown in the right inset where the razor's edge occupies the middleof the blade 20. FIG. 23B illustrates a serrated configuration, and FIG.23C a toothed configuration. The serrated and tooth configurations mayalso have an internal razor's edge, internal razor's edge, or doubleedged where the razor's edge is in the middle of the blade.

FIGS. 24A-24E schematically depicts structure and deployment operationsof a rotary cutting specimen chamber 190. In FIG. 24A the specimenchamber 190 is plunged into the target tissue to effect cutting viacutting edge or cutting circumference 192. Specimen chamber 190 is thenrotated and counter rotated to effect cutting with cutting wire 194spanning across the middle of the forward presenting lumen face ofspecimen chamber 190. In FIG. 24B, upon plunging into tissue limited bythe depth set by depth stops 18, the cutting wire bisects the tissuespecimen equally into two halves. Each half of the tissue specimen iskept separated by tissue divider 196.

FIG. 24C depicts a perspective view of the specimen chamber 190 withdeployment of depth stops 18 from the sheath 14. In an alternateembodiment, the cutting wire 194 may be replaced with a cutting wedge198. The specimen divider 196 similarly preserves the specimen halves,their tissue integrity, sampling order and orientation.

FIGS. 24D-E illustrate perspective and side views of the specimenchamber 190 with deployed depth stops 18.

FIGS. 25A-25F schematically depicts structure and deployment operationsof the perpendicular double cantilevered blade single axis specimenchamber 188 in the sequential or consecutive acquisition of histologicalgrade tissue specimens temporarily housed within the specimen chamber188.

Presented in FIGS. 25A and 25B is the deployment of four depth stops 18.Top views show the depth stops retracted within sheath 14 in FIG. 25Aand then deployed in FIG. 25B.

In FIG. 25C the specimen chamber 188 is deployed beyond the terminus ofsheath 14, readied for plunging into tissue to procure a specimen.

FIG. 25D previously acquired specimens are pushed or displaced downward(wide, white motion arrows) upon thrusting or plunging action of thespecimen chamber 188 into a tissue sampling site chosen by the operatorindicated in FIGS. 7 and 10.

FIG. 25E illustrates commencement of cutting action by blades 162/166when a downward motion to blade control wire 37 is effected by a pullingaction applied by the operator to thumbhole 66 of multifunction handle50 shown in FIG. 2 engages the mutual counter rotation of blades 162/166via cable's 37 connection with lever projections 164/168 to a midpointin blades 162/166 cutting action.

FIG. 25F illustrates completion of cutting action by blades 162/166 whenthe downward motion to blade control wire 37 is effected by completionof pushing force applied by the operator to thumbhole 66 ofmultifunction handle 50 shown in FIG. 2. The just cut specimen then maybe displaced into the lumen of the specimen chamber 188 by retraction ofthe blades 162/166 to their stored state via a pulling force applied tothe thumbhole 66 of multifunction handle 50 and then re-plunging thechamber 188 at another sample site depicted in FIG. 25D.

FIG. 26 presents a perspective view of the specimen chamber 16 inrelation to the sheath 14.

FIG. 27 presents an alternate embodiment depiction of the MCB 10depicted in FIG. 1.

FIG. 28 presents a side view depiction of an alternate embodiment to themultifunction handle 50 depicted in FIG. 2.

FIG. 29 presents another depiction of the depth stop 18 deployment fromthe MCB 10 described in FIG. 12A.

FIG. 30 presents another depiction of the setting of the specimenchamber's 16 plunging distance and advancement to that plunging distancefrom the MCB 10 described in FIG. 12B.

FIG. 31 presents another depiction of the initiation of cutting actionby the blade 20 from specimen chamber 16 from the MCB 10 described inFIG. 12C.

FIG. 32 presents another depiction of the cutting action by the blade 20from specimen chamber 16 and storage of multiple tissue sections storedwithin the specimen chamber 16 from the MCB 10 described in FIG. 12D.

FIG. 33 present alternate cross-sectional and perspective viewsdepicting specimen chamber 188 deployment and blade operation shown inFIGS. 25A-F above.

FIG. 34 presents additional cross-sectional and perspective viewsspecimen chamber 188 deployment and blade operation depicted in FIGS.25A-F above.

FIG. 35 presents another side view and perspective depiction of therigid multi-core specimen biopsy device 200 depicted in FIG. 5 above.

FIG. 36 schematically depicts side and cross-sectional views of anotherdepiction of proximal specimen chamber 80 connectable with themulti-function handle 50 for specimen retrieval via aspiration or gentlesuction directed to the biopsy access port 68 from the distal chamber 16into the proximal chamber 80 with preservation of specimen samplingorder and specimen orientation.

FIG. 37 schematically depicts side and cross-sectional views ofretrieval of the multiple tissue specimens 19 from the distal specimenchamber 16 via fluid flushing from syringe 355 connected to the biopsyaccess port 68. The flushed tissues are ejected from the distal specimenchamber 16 into a net 360 fitted with closure 365 with preservation ofsampling order and specimen orientation.

The foregoing described above provides for embodiments of a MCB 10 and100 devices and an SMS that quickly retrieves multiple anatomical tissuespecimens for safe storage and management for histopathologicalassessment. The MCB and SMS intrinsic orientation saves a substantialamount of time for the pathologist and physician via sequential samplingof a single insertion event compared to single sampling of multipleinsertion events.

Other embodiment of the MCB 10 or MCB 100 provide for completeaspiration of the multiple specimen's into the proximal specimenmanagement chamber attached to the proximal handle 50. This allows forunlimited number of biopsies taken in a single pass, in other wordswithout removing the MCB from the endoscope.

Other embodiment of the MCB 10 or MCB 100 further provide for a styletto be inserted into the center of the core biopsy to maintain rigidityas it is used to thrust into a submucosal tumor. Once positioned indirect view using an Endoscopic Ultrasound Scope the stylet is removedand a series of biopsy's are taken as describe above.

While the preferred embodiment of the invention has been illustrated anddescribed, as noted above, many changes can be made without departingfrom the spirit and scope of the invention. For example, otherembodiments may include multiple ports for adaptable multiple flushingsyringes having different fluids. Accordingly, the scope of theinvention is not limited by the disclosure of the preferred embodiment.The design of taking multiple biopsies in this embodiment is applicableto any surgical and non-surgical endoscopy for any part of the body. Itis not limited to only endoscopy but any surgical modality where tissuespecimens are taken or used for tumors extraction. In fact this devicecan operate without the outer sheath and depth stops in certain surgicalapplications. Instead, the invention should be determined entirely byreference to the claims that follow.

1. A biopsy device operable through an endoscope by a user comprising: aflexible sheath having a terminus with a distal chamber configured witha forward facing cutting edge comprising a fixed blade and at least onemovable blade; and a manipulation end controllable by the user to plungethe forward facing cutting edge at a set depth or a depth selected bythe user and to engage a cutting action by the at least one movableblade at the set depth or the depth selected to acquire a plurality ofspecimens storable in the distal chamber.
 2. The biopsy device of claim1, wherein the fixed blade and the at least one movable blade areconfigured perpendicular to the long axis of the chamber.
 3. The biopsydevice of claim 1, wherein the fixed blade and the at least one movableblade are configured angular to the long axis of the chamber.
 4. Thebiopsy device of claim 1, wherein the at least one movable blade ispivotable about a single axis.
 5. The biopsy device of claim 1, whereinthe at least one movable blade comprises two counter rotating bladesconfigured perpendicular to the long axis of the chamber and pivotableabout a single axis shared between the two counter rotating blades. 6.The biopsy device of claim 1, wherein the at least one movable bladecomprises two counter rotating blades configured angular to the longaxis of the chamber and pivotable about a single axis shared between thetwo counter rotating blades.
 7. The biopsy device of claim 1, whereinthe at least one movable blade comprises two counter rotating bladesconfigured perpendicular to the long axis of the chamber, each counterrotating blade configured to pivot from a separate axis.
 8. The biopsydevice of claim 1, wherein the at least one movable blade comprises twocounter rotating blades configured angular to the long axis of thechamber, each counter rotating blade configured to pivot from a separateaxis.
 9. The biopsy device of claim 1, wherein the forward facingcutting edge includes a wire spanning across the middle of the forwardfacing cutting edge and a plate beneath the wire, wherein the pluralityof specimens are cut the long axis to form a plurality of specimen halfpairs, the specimen half pair kept separated by the plate.
 11. Thebiopsy device of claim 1, wherein the at least one moveable blade isinitiated by a pulling action from the manipulation end.
 12. The biopsydevice of claim 1, wherein the at least one moveable blade is initiatedby a pushing action from the manipulation end.
 13. The biopsy device ofclaim 1, wherein the set depth or the depth selected is effected by thedeployment of depth stops from the flexible sheath adjacent to thedistal chamber initiated from the manipulation end.
 14. The biopsydevice of claim 1, wherein the manipulation end includes a proximalchamber in fluid communication with the distal chamber, the proximalchamber configured to receive the plurality of specimens in the orderand orientation acquired upon exposure of a suction conveyed through theflexible sheath.
 15. The biopsy device of claim 1, wherein the pluralityof specimens are removed from the distal specimen chamber by a flushingfluid conveyed from the manipulation end with preservation of specimenorder and orientation.
 16. A biopsy system operable through an endoscopeby a user comprising: a flexible sheath having a terminus with a distalchamber configured with a forward facing cutting edge comprising a fixedblade and at least one movable blade; an a manipulation end controllableby the user to plunge the forward facing cutting edge at a set depth ora depth selected by the user and to engage a cutting action by the atleast one movable blade at the set depth or the depth selected toacquire a plurality of specimens storable in the distal chamber; and aproximal chamber in fluid communication with the distal chamber, theproximal chamber configured to receive the plurality of specimens in theorder and orientation acquired upon exposure of a suction conveyedthrough the flexible sheath.
 17. The biopsy system of claim 16, whereinthe fixed blade and the at least one movable blade are configuredperpendicular to the long axis of the chamber.
 18. The biopsy system ofclaim 16, wherein the fixed blade and the at least one movable blade areconfigured angular to the long axis of the chamber.
 19. The biopsysystem of claim 16, wherein the at least one movable blade is pivotableabout a single axis.
 20. The biopsy system of claim 16, wherein the atleast one movable blade comprises two counter rotating blades configuredperpendicular to the long axis of the chamber and pivotable about asingle axis shared between the two counter rotating blades.
 21. Thebiopsy system of claim 16, wherein the at least one movable bladecomprises two counter rotating blades configured angular to the longaxis of the chamber and pivotable about a single axis shared between thetwo counter rotating blades.
 22. The biopsy system of claim 16, whereinthe at least one movable blade comprises two counter rotating bladesconfigured perpendicular to the long axis of the chamber, each counterrotating blade configured to pivot from a separate axis.
 23. The biopsysystem of claim 16, wherein the at least one movable blade comprises twocounter rotating blades configured angular to the long axis of thechamber, each counter rotating blade configured to pivot from a separateaxis.
 24. The biopsy system of claim 16, wherein the forward facingcutting edge includes a wire spanning across the middle of the forwardfacing cutting edge and a plate beneath the wire, wherein the pluralityof specimens are cut the long axis to form a plurality of specimen halfpairs, the specimen half pair kept separated by the plate.
 25. A biopsydevice having a removable stylet, the biopsy used operable by a personused with an image-guided system comprising: a rigid sheath equippedwith the removable stylet, the rigid sheath having depth markingsvisible by the image-guided system and a terminus with a distal chamberconfigured with a forward facing cutting edge comprising a fixed bladeand at least one movable blade; and a manipulation end controllable bythe user to plunge the forward facing cutting edge at a sampling locusafter removal of the stylet at a depth selected by the user based on thedepth markings and to engage a cutting action by the at least onemovable blade at the depth selected to acquire at least one specimenstorable in the distal chamber.
 26. The biopsy device of claim 20,wherein additional specimens may be acquired at deeper depths at thesampling locus.
 27. A method to acquire biopsy specimens from aregion-of-interest using a system operable through the internal orexternal biopsy channel of an endoscope tube residing internally withina patient manipulatable by a user, the method comprising: inserting aflexible sheath fitted with a specimen chamber fitted with a forwardfacing cutting edge through and beyond the terminus of the biopsychannel to place the specimen chamber near the region-of-interest;manipulating the specimen chamber via a handle in mechanical contactwith the specimen chamber to deploy a plurality of depth stops andextend the specimen chamber beyond the terminus of the flexible sheathat a set or selected distance by the user; plunging the specimen chamberforward facing cutting edge into tissues occupying theregion-of-interest to the set or selected distance; acquiring andstoring a plurality of specimens in the specimen chamber; and procuringthe plurality of specimens from the specimen chamber in the order andorientation acquired.